Famotidine Normon 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Famotidina Normon 20 mg film-coated tablets EF G

Famotidine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Famotidina Normon is and what it is used for
2. What you need to know before taking Famotidina Normon
3. How to take Famotidina Normon
4. Possible adverse effects
5. How to store Famotidina Normon
6. Contents of the pack and other information

1. What Famotidina Normon is and what it is used for

Famotidina Normon belongs to a group of medicines called histamine H2-receptor antagonists or H2 blockers. Famotidine reduces the amount of acid produced in the stomach.

Famotidine is indicated for the treatment of duodenal ulcer, benign gastric ulcer, and for the prevention of their recurrence. It is also used in other conditions in which the stomach produces excessive acid, such as Zollinger-Ellison syndrome, gastroesophageal reflux disease, and reflux esophagitis.

Famotidina Normon is indicated for use in adults.

2. What you need to know before starting to take Famotidina Normon

Do not take Famotidina Normon

• If you are allergic (hypersensitive) to famotidine, to other H2-receptor antagonists, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Before starting treatment, your doctor must rule out the presence of more serious diseases. Relief of gastric ulcer symptoms during treatment may delay the diagnosis of such conditions.
• Do not stop treatment abruptly. Discontinuation of treatment must always be gradual and according to your doctor's instructions to avoid relapse.

Consult your doctor or pharmacist before starting to take Famotidina Normon:

• If you have moderate or severe kidney disease. Your doctor will indicate a reduced dosing frequency or a lower dose.
• If you are elderly, as you may have kidney problems.

Children and adolescents

The safety and efficacy of this medicine have not been established in children.

Use in people aged 65 years and older

Patients aged 65 years and older only require dose adjustment in cases of moderate or severe renal impairment.

Taking Famotidina Normon with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine.

• Calcium carbonate, when used to treat high blood phosphate levels (hyperphosphatemia) in dialysis patients.
• Famotidina Normon may reduce the effect of oral posaconazole suspension (a medicine used to prevent and treat certain fungal infections).
• Famotidina Normon may reduce the effect of dasatinib, erlotinib, gefitinib, or pazopanib (medicines used to treat cancer).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Treatment with famotidine is not recommended during pregnancy. You must inform your doctor if you are pregnant or plan to become pregnant.

Famotidine has been detected in breast milk. Breastfeeding mothers should either discontinue treatment with famotidine or stop breastfeeding.

Driving and using machines

Although effects in this regard are not expected, if dizziness occurs, you should not drive or operate dangerous machinery.

3. How to take Famotidine Normon

Follow exactly the dosing instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Treatment of duodenal ulcer: The recommended dose is 2 tablets (40 mg of famotidine) at bedtime. Alternatively, 1 tablet (20 mg of famotidine) every 12 hours may be administered. Treatment should be continued for 4 to 8 weeks.

Treatment of benign gastric ulcer: The recommended dose is 2 tablets (40 mg of famotidine) at bedtime. Treatment should be continued for 4 to 8 weeks.

Maintenance treatment of gastric or duodenal ulcer: 1 tablet (20 mg of famotidine) at bedtime is recommended. Your doctor will indicate how long you should take the medicine.

Treatment of gastroesophageal reflux disease (GERD): The recommended dose is 1 tablet (20 mg of famotidine) twice daily. If there is no improvement after 4–8 weeks, consult your doctor.

Treatment of reflux esophagitis: The recommended dose is 2 tablets (40 mg of famotidine) twice daily. If there is no improvement after 4–8 weeks, consult your doctor.

Zollinger-Ellison syndrome: Treatment usually starts with a dose of 1 tablet (20 mg) every 6 hours. Your doctor will subsequently adjust the dose according to individual patient needs.

It is very important that you continue taking this medicine for the duration prescribed by your doctor, as pain usually resolves before the ulcer is completely healed.

Use in patients with moderate or severe renal impairment

Your doctor will decide whether a dose adjustment is necessary, either by reducing the dose by half or by increasing the interval between doses.

Elderly patients only require dose adjustment if they have renal impairment.

Method of administration

Take the tablets with water. Famotidine Normon may be taken with or without food.

The tablet may be divided into equal doses.

Your doctor will tell you how many tablets to take each day and for how long. Do not stop treatment prematurely. If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Famotidine Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, stating the medicine and the amount ingested. If possible, bring this leaflet or the container with you and show it to the healthcare professional.

If you forget to take Famotidine Normon

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people):

• Headache
• Dizziness
• Diarrhoea
• Constipation

Uncommon (may affect up to 1 in 100 people):

• Loss of appetite
• Fatigue
• Nausea
• Vomiting
• Abdominal discomfort or bloating
• Dry mouth
• Excessive intestinal gas
• Skin rash
• Itching
• Joint pain
• Muscle cramps
• Reversible psychiatric disorders including depression, anxiety disorders, agitation, confusion, and hallucinations

Rare (may affect up to 1 in 1,000 people):

• Cholestatic jaundice (yellowing of the skin and eyes due to problems with bile secretion)
• Urticaria (skin rash)
• Anaphylaxis (unusual or exaggerated allergic reaction)
• Angioneurotic edema (severe allergic reaction with breathing difficulty, urticaria, and swelling of the face, lips, tongue, throat, and even limbs, possibly causing difficulty in swallowing or breathing)

Very rare (may affect up to 1 in 10,000 people):

• Hair loss
• Laboratory findings: Abnormal liver enzymes
• Toxic Epidermal Necrolysis (skin peeling)

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Famotidine Normon

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, following "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Famotidine Normon

• The active substance is famotidine. Each tablet contains 20 mg of famotidine.

• The other components (excipients) are:

• Tablet core: pregelatinized maize starch, microcrystalline cellulose, talc, magnesium stearate.

• Film coating: hypromellose, titanium dioxide (E-171), macrogol 6000, and yellow iron oxide (E-172).

Appearance of the product and contents of the container

Famotidine Normon 20 mg film-coated tablets EFG are presented in aluminum/PVC blisters. Each pack contains 28 yellow, round, biconvex, film-coated tablets with a score line.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

• 28760 Tres Cantos – Madrid

(SPAIN)

Date of the most recent review of this leaflet: August 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/66093/P_66093.html